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Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive lymphoma. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate. The study seeks to explore the possibility of improving the efficacy of immunotherapy and chemotherapy and epigenetically regulated drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with new diagnosed angioblastic T cell lymphoma | Experimental | Patients with new diagnosed angioblastic T cell lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone | Drug | tislelizumab: 200mg on d1 every 3 weeks; chidamide: 20mg twice a week at least 3 days apart; cyclophosphamide: 750mg/m2 on Day 1 of each cycle, every 4 weeks; mitoxantrone liposomes: 20mg/m2 on Day 1, every 4 weeks; prednisone: 100mg/day on Day 1 to Day 5 of each course, every 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Measure | To evaluate the Objective Response Rate (Complete response+Partial response) of tirelizumab in combination with cyclophosphamide, mitoxantrone liposomes, sidaraniline, and prednisone in subjects with relapsed/refractory angioimmunoblastic T-cell lymphoma | Time forecasting: 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 24-month Overall Survival Rate in relapsed/refractory AITL | Proportion of patients alive at 24 months after initiation of tirelizumab combination therapy | From first dose until death from any cause (assessed at 24 months) |
| 24-month Progression-free Survival Rate in relapsed/refractory AITL |
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Inclusion Criteria:
Pathological diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014 criteria: lymph node lesion, detectable lymph node length>1.5cm; non-lymph node lesion, detectable extra-nodal lesion length>1.0cm;
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible for inclusion in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Sang Doctor | Contact | 136452076 | sw1981726@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221000 | China |
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|
Proportion of patients without disease progression at 24 months per Lugano 2014 criteria |
| From first dose until first documented progression or death (assessed at 24 months) |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Time forecasting: 24 months |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D003520 | Cyclophosphamide |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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